Six year wait for Humira biosimilar a win-win for Amgen and AbbVie, says lawyer

By Dan Stanton

- Last updated on GMT

Humira biosimilar settlement a 'win-win' for Amgen and AbbVie, lawyer

Related tags Monoclonal antibodies Etanercept

AbbVie’s settlement over the exclusivity of Humira creates a level of certainty for Amgen’s adalimumab biosimilars, according to a biotech lawyer.

Amjevita (adalimumab- atto) became the first biosimilar version of AbbVie’s best-selling monoclonal antibody Humira to be approved in the US last September​. European approval came in January​ under the name Amgevita.

Neither product has been launched due to long-standing legal battles between AbbVie and Amgen over the intellectual property of Humira, but last week the two firms resolved the dispute.

Amgen will now be able to launch Amjevita in the US from January 31 2023, while across the pond AbbVie has agreed to a licensing date of October 16 2018, allowing Amgen to launch Amgevita in most EU countries.

“In reaching this agreement, we have achieved the balance between protecting investment in innovation and providing access to biosimilars, which will play an important role in our health care system,” ​Laura Schumacher, EVP of external affairs, general counsel and corporate secretary at AbbVie said in a statement.

“We will continue to defend our intellectual property and to reinvest in further advancements in medicine to bring choices to patients in need.”

Kevin Noonan, partner at Chicago-based McDonnell Boehnen Hulbert & Berghoff LLP and chair of the firm’s Biotechnology & Pharmaceuticals Practice Group, said the settlement brings a level of certainty to an enduring issue surrounding adalimumab exclusivity.

“It is a win for AbbVie but arguably also a win for Amgen and the public,”​ he told Biopharma-Reporter. “The Amgen launch date is earlier than the patent expiry date(s), and this settlement brings certainty.”

Humira brought in revenues of over $16bn​ for AbbVie last year, and Amgen is not the only company looking to take a slice of the adalimumab market. Cyltezo, made by Boehringer-Ingelheim, became the second version of Humira (and sixth specific biosimilar product) to be approved in the US in August​.

According to Noonan, the Amgen-AbbVie agreement might set some precedent in any separate patent battle and make settlement easier if competitors can get the same entry date. However, “litigation might still ensue by parties hoping to get an earlier date.”

Related topics Markets & Regulations Biosimilars

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